【Purpose & Scope】
・Accountable and responsible for development and implementation of a global medical development plan on a large complex late-phase project or on a group of complex
・Serves as global medical lead (GML) on one or multiple Astellas Pharma Global Development (APGD) Core teams including late stage and complex projects.
・Responsible for designing and conducting a global medical program resulting in quality regulatory submissions.
・Responsible for the medical interface with research through regulatory authorities and the commercial organization.
・Provides medical leadership on the Global Project Team and chairs the Global Clinical Team meetings.
・Supports to other projects as required.
【Essential Job Responsibilities】
・Accountable and responsible for design and final recommendations in clinical development plan for their drug (s), after soliciting appropriate input and review from colleagues within Regulatory Affairs, Commercial, and Medical Affairs (Global and Regional), Manufacturing, Clinical Pharmacology, Statistics, Health Economics and Outcomes Research and other line functions.
・Leads the global medical team(s) to design, implement and conduct multi-phase development studies globally to support filing of successful regulatory submissions and supplemental filings post approval.
・Leads APGD medical programs when required as part of post marketing requirements.
・Accountable and responsible for execution and delivery of the clinical development plan (in conjunction with Global Development Project Leader (GDPL)).
・Acquires public knowledge of present and future competitor products and how they impact the internal medical and commercial strategy.
・Negotiates milestones and ensures clinical development objectives are met (in conjunction with Global Project Development Leader).
・Plans for resources required both within the Medical Sciences organization and in conjunction with the Global Development Project Lead (GDPL) and the Global Development Operations Lead (GDOL) to accomplish the objectives in a timely and resource-efficient fashion. This includes the number of employees and contractors needed.
・Responsible, in collaboration with Clinical Sciences, for developing, recommending, adhering to the clinical development budget.
・Motivates global medical team towards the common goal of submitting approvable regulatory filings (in conjunction with Global Project Development Leader).
・Contributes to Global Project Team meetings.
・Responsible for keeping GDPL, other project physicians, VP Global Medical Science TA Head informed of clinical progress and any critical medical issues and especially the emerging safety profile.
・Coordinates and authors protocol synopses, major protocol amendments and communicates upcoming changes to the Vice President Global Medical Science TA Head.
・Provides input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions.
・May plan and convene clinical expert panel meetings and advisory boards that provide input into drug development plans.
・Presents to senior management and external audiences various medical aspects of drug development, including milestones, strategies, and recent data and anticipate obstacles to or changes to approved plans.
・Incorporates Health Economics Outcomes Research requirements into protocol design.
■休日：完全週休二日制, GW, 祝日, 年末年始, 土, 夏季休暇, 日